To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers

NCT ID: NCT06361277

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2023-11-27

Brief Summary

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Detailed Description

Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Group Type: OTHER

Reference Drug or Test Drug

Intervention Type: DRUG

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Group 2

Treatment A: Co-administration of 2 tablets of C2205 and JW0201 Treatment B: Co-administration of 2 tablets of JW0202 and C2202

Tablet, Oral, QD for 1 Day, Washout period is more than 21 days after administration

Group Type: OTHER

Reference Drug or Test Drug

Intervention Type: DRUG

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Interventions

Reference Drug or Test Drug

Tablet, Oral, QD for 1 Day, Washout period is more than 7 days after administration

Intervention Type: DRUG

Other Intervention Names

Reference Drug(C2205 and JW0201) or Test Drug(JW0202 and C2202)

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MinGul Kim

Role: PRINCIPAL_INVESTIGATOR

Jeonbuk National University Hospital

Locations

Clinical Trial Center, Jeonbuk National University Hospital

Jeonju, , South Korea

Countries

South Korea

Other Identifiers

JW22104

Identifier Type: -

Identifier Source: org_study_id